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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Class Implantable

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CLEAR GUIDE MEDICAL, INC.
CGSCENERGY
In Commercial Distribution

  • B201CGSCENERGY1 ()
  • B201CGSCENERGY0 ()


  • Ultrasound imaging system application software
  • Stereotactic system application software
No Description
Exo Imaging, Inc.
EW1001
In Commercial Distribution

  • 00850018318013 ()


  • Ultrasound imaging system application software
VistaScan™ Software 1.x.x
EMAGINE SOLUTIONS TECHNOLOGY LLC
1.x.x
In Commercial Distribution

  • 00850017464001 ()


  • Ultrasound imaging system application software
jFit Software
JOINTVUE, LLC
1.0
Not in Commercial Distribution

  • 00850014885021 ()


  • Ultrasound imaging system application software
Software Application
Vave Health, Inc.
VUA
Not in Commercial Distribution

  • 00850001977043 ()
VUA

  • Ultrasound imaging system application software
Koios Decision Support (DS) is a software application designed to assist trained interpreting physicians in analyzing breast and thyroid ultrasound images. The software device is a web application that is deployed to a Microsoft IIS web server and accessed by a user through a compatible client. Once logged in and granted access to the Koios DS application, the user examines selected breast or thyroid ultrasound DICOM images. The user selects Regions of Interest (ROIs) of orthogonal views of a breast lesion or thyroid nodule for processing by Koios DS. The ROI(s) are transmitted electronically to the Koios DS server for image processing and the results are returned to the user for review.
KOIOS MEDICAL, INC.
3.x
In Commercial Distribution

  • 00860002545714 ()


  • Ultrasound imaging system application software
The Koios DS Breast system is designed to assist qualified interpreting physicians in analyzing breast ultrasound images by providing a system generated categorical output that aligns with or exceeds the sensitivity and specificity of radiologist chosen BI-RADS categorizations using computer vision and machine learning techniques. Koios DS Breast may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software includes tools that allow users to adjust, measure and document images, and output into a structured report.
KOIOS MEDICAL, INC.
2.x
In Commercial Distribution

  • 00860002545707 ()


  • Ultrasound imaging system application software
Localization and characterization of thyroid ultrasound images.
SEE-MODE TECHNOLOGIES PTE. LTD.
See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
In Commercial Distribution

  • 00860006305727 ()


  • Ultrasound imaging system application software
Analysis and reporting of vascular ultrasound images
SEE-MODE TECHNOLOGIES PTE. LTD.
AVA (Augmented Vascular Analysis)
In Commercial Distribution

  • 00860006305703 ()


  • Ultrasound imaging system application software
MediScout® is an augmented reality accessory to clinical ultrasound (US) systems, with the ability to holographically display the US image for the user as well as provide procedural annotation and a teleprodecural function for remote practitioner collaboration.
Mediview Xr, Inc.
MS-100-1001
In Commercial Distribution

  • 00860006066307 ()


  • Ultrasound imaging system application software
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